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Offering Savings & Support for Eligible Commercial Patients

Eligible commercial patients may be able to save on their ONFI prescriptions

Have them follow the activation instructions on the card and bring the 14-Day Voucher and 14-day prescription to the pharmacist.* See complete Terms and Conditions below

Eligible commercial patients may save on their prescription copay

The Copay Savings Card can help eligible patients save on their prescription copay.* Patients may pay as little as $10 per 30-day prescription. A maximum benefit of $600 may apply for each 30-day prescription. See complete Terms and Conditions below

Call ONFI Support Center for support at 1-855-345-6634

*Medicaid patients and other federal health care program beneficiaries, patients who are self-pay, and patients who do not have insurance coverage for ONFI are not eligible. Eligible commercial patients must be at least 2 years old to participate. See complete Terms and Conditions for each program below.

Terms and Conditions for the ONFI 14-Day Free Trial and Copay Assistance Programs

General Terms and Conditions: Only commercially insured patients age 2 and older whose insurance policy provides coverage for ONFI® (clobazam) and who are not reimbursed for the entire cost of the prescription are eligible for the 14-day free trial voucher or copay assistance (the "Offers"). Patients are not eligible for the Offers if they are self-pay or if the prescription is eligible to be reimbursed, in whole or in part, by any state or federal health care programs, including but not limited to Medicare or Medicaid, Medigap, VA, DOD, or TRICARE. In addition, patients may not use the Offers if they are Medicare-eligible and enrolled in an employer-sponsored health plan or prescription drug benefit program for retirees.

Offers are valid only for use with a valid prescription for ONFI at the time the prescription is filled by the pharmacist and dispensed to the patient. Offers apply only to prescriptions filled before the programs expire. The free trial and copay prescriptions shall not be submitted for reimbursement to any public third-party payer, including Medicaid or Medicare or any other similar federal or state healthcare program; in addition, the free trial prescription shall not be submitted to any private third-party payer. Patients are responsible for complying with any obligations or requirements imposed by their insurance plans.

The Offers are not transferable. The selling, purchasing, trading, or counterfeiting of the Offers is prohibited by law. The Offers have no cash value and may not be used in combination with any other discount, coupon, rebate, free trial, or similar offer for the specified prescription.

Lundbeck reserves the right to rescind, revoke, or amend the Offers without notice. Offers are intended to comply with all applicable laws and regulations, including, without limitation, the federal Anti-Kickback Statute, its implementing regulations, and related guidance interpreting the federal Anti-Kickback Statute. Offers are not health insurance. Offers are valid only in the USA where allowed by law. There is no future purchase requirement associated with the Offers. Patient questions and requests to discontinue participation in the programs can be directed to 1-855-809-5818 (8:00 am-8:00 pm ET, Monday through Friday).

14-Day Free Trial Terms and Conditions: To participate in this program, eligible commercially insured patients age 2 and older must present the 14-day free trial voucher to the pharmacist along with their valid prescription. By participating in the 14-Day Free Trial, the patient acknowledges and agrees that he/she is eligible to participate and that he/she understands and agrees to comply with the General and 14-Day Free Trial Terms and Conditions.

Copay Assistance Terms and Conditions: Eligible patients must present their activated card to the pharmacist along with their valid Onfi prescription to participate in this program. The offer is valid for up to 12 prescription fills of a 30-day supply each. Use of the Copay Assistance program will require patients to pay a minimum of $10 out-of-pocket expense for each 30-day prescription. To be eligible, patients must have a copay that exceeds $10 for each 30-day prescription. A maximum benefit of $600 may apply for each 30-day prescription. If the patient’s total out-of-pocket pharmacy bill exceeds the cap established by Lundbeck, the patient will be responsible for the additional balance. Patients should talk to their pharmacist to determine the maximum amount that they could pay based on their prescribed dosage and insurance benefits. By participating in the Copay Assistance program, the patient acknowledges and agrees that he/she is eligible to participate and that he/she understands and agrees to comply with the General and Copay Assistance Terms and Conditions.

To the Pharmacist:

Submit transaction to McKesson Corporation using BIN #610524.

For the copay card, if primary coverage exists, input card information as secondary coverage and transmit using the COB segment of the NCPDP transaction. Applicable discounts will be displayed in the transaction response.

Acceptance of this card and your submission of claims are subject to the LoyaltyScript® program. Terms and Conditions posted at www.mckesson.com/mprstnc.

ONFI SUPPORT CENTER

†Complete Terms and Conditions for the 14-Day Trial and Commercial Copay Assistance Programs are available here.

IMPORTANT SAFETY INFORMATION

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS

See full Prescribing Information for complete boxed warning.

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.

Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.

Limit dosages and durations to the minimum required.

Follow patients for signs and symptoms of respiratory depression and sedation.

Contraindication: Hypersensitivity

ONFI is contraindicated in patients with a history of hypersensitivity to the drug or its ingredients. Hypersensitivity reactions have included serious dermatological reactions.

Risks from Concomitant Use with Opioids (see Boxed Warning)

Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. If a decision is made to prescribe ONFI concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use. Advise both patients and caregivers about the risks of respiratory depression and sedation when ONFI is used with opioids.

Potentiation of Sedation from Concomitant Use with Central Nervous System (CNS) Depressants

ONFI has a CNS depressant effect. Caution patients or their caregivers against simultaneous use with other CNS depressant drugs or alcohol and that the effects of other CNS depressant drugs or alcohol may be potentiated.

Somnolence or Sedation

ONFI causes somnolence and sedation. In clinical trials, somnolence or sedation was reported at all effective doses and was dose-related. In general, somnolence and sedation begin within the first month of treatment and may diminish with continued treatment. Monitor patients for somnolence and sedation, particularly with concomitant use of other CNS depressants. Caution patients against engaging in hazardous activities that require mental alertness, such as operating dangerous machinery or motor vehicles, until the effect of ONFI is known.

Withdrawal Symptoms

As with all antiepileptic drugs (AEDs), withdraw ONFI gradually to minimize the risk of precipitating seizures, seizure exacerbation, or status epilepticus. Withdrawal symptoms occurred following abrupt discontinuation of ONFI; the risk of withdrawal symptoms is greater with higher doses.

Serious Dermatological Reactions

Serious skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported with ONFI in both children and adults during the post-marketing period. Discontinue ONFI at the first sign of rash, unless the rash is clearly not drug-related.

Physical and Psychological Dependence

Carefully monitor patients with a history of substance abuse when receiving ONFI or other psychotropic agents because of the predisposition of such patients to habituation and dependence. In clinical trials, cases of dependency were reported following abrupt discontinuation of ONFI. The risk of dependence increases with increasing dose and duration of treatment.

Suicidal Behavior and Ideation

AEDs, including ONFI, increase the risk of suicidal thoughts or behavior in patients. Inform patients, their caregivers, and families of the risk and advise them to monitor and report any emergence or worsening of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts of self-harm. If these symptoms occur, consider whether it may be related to the AED or illness, because epilepsy itself can increase these risks.

Pregnancy, Registry and Nursing Mothers

Based on animal data, ONFI may cause fetal harm and should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.

IMPORTANT SAFETY INFORMATION

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.

Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.

Limit dosages and durations to the minimum required.

Follow patients for signs and symptoms of respiratory depression and sedation.

Contraindication: Hypersensitivity

ONFI is contraindicated in patients with a history of hypersensitivity to the drug or its ingredients. Hypersensitivity reactions have included serious dermatological reactions.

Risks from Concomitant Use with Opioids (see Boxed Warning)

Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. If a decision is made to prescribe ONFI concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use. Advise both patients and caregivers about the risks of respiratory depression and sedation when ONFI is used with opioids.

Potentiation of Sedation from Concomitant Use with Central Nervous System (CNS) Depressants

ONFI has a CNS depressant effect. Caution patients or their caregivers against simultaneous use with other CNS depressant drugs or alcohol and that the effects of other CNS depressant drugs or alcohol may be potentiated.

Somnolence or Sedation

ONFI causes somnolence and sedation. In clinical trials, somnolence or sedation was reported at all effective doses and was dose-related. In general, somnolence and sedation begin within the first month of treatment and may diminish with continued treatment. Monitor patients for somnolence and sedation, particularly with concomitant use of other CNS depressants. Caution patients against engaging in hazardous activities that require mental alertness, such as operating dangerous machinery or motor vehicles, until the effect of ONFI is known.

Withdrawal Symptoms

As with all antiepileptic drugs (AEDs), withdraw ONFI gradually to minimize the risk of precipitating seizures, seizure exacerbation, or status epilepticus. Withdrawal symptoms occurred following abrupt discontinuation of ONFI; the risk of withdrawal symptoms is greater with higher doses.

Serious Dermatological Reactions

Serious skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported with ONFI in both children and adults during the post-marketing period. Discontinue ONFI at the first sign of rash, unless the rash is clearly not drug-related.

Physical and Psychological Dependence

Carefully monitor patients with a history of substance abuse when receiving ONFI or other psychotropic agents because of the predisposition of such patients to habituation and dependence. In clinical trials, cases of dependency were reported following abrupt discontinuation of ONFI. The risk of dependence increases with increasing dose and duration of treatment.

Suicidal Behavior and Ideation

AEDs, including ONFI, increase the risk of suicidal thoughts or behavior in patients. Inform patients, their caregivers, and families of the risk and advise them to monitor and report any emergence or worsening of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts of self-harm. If these symptoms occur, consider whether it may be related to the AED or illness, because epilepsy itself can increase these risks.

Pregnancy, Registry and Nursing Mothers

Based on animal data, ONFI may cause fetal harm and should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.

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